Effect of Antibiotics as an Adjuvant to Scaling and Root Planing on Systemic Inflammation in Patients With Periodontitis - A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- High senstivity C-reactive protein (hsCRP)
研究概览
简要总结
Evidence support that pathogenic bacteria are not only responsible for periodontal destruction but also contributes to systemic inflammatory burden either directly or indirectly through increase in pro-inflammatory cytokines. Scaling and root planing (SRP) with or without local antibiotics contributes to reduced systemic inflammation. However, studies also reported insignificant changes in systemic inflammation after SRP. It may be due to incomplete control of periodontal inflammation. Systemic antibiotics proves to beneficial in treatment of severe periodontitis. Systemic antibiotics along with SRP results in improvement of vascular health and systemic inflammation. However, till date no study has been done to evaluate the role of systemic antibiotics as an adjunct to SRP on systemic inflammatory markers. In this randomized control study impact of adjunctive use of systemic antibiotics along with SRP on systemic inflammation would be assessed in periodontitis patients.
详细描述
Periodontitis is characterized by microbially-associated, host-mediated inflammation that results in loss of periodontal attachment. Periodontal bacteria possess a plethora of virulence factors that induce cells to produce inflammatory mediators at the gingival level.
Periodontitis is associated with bacteraemia that arises from perturbation of ulcerated periodontal tissues by simple acts of tooth brushing, eating and also during periodontal interventions disseminating whole bacteria and their products and toxins such as LPS. Virulence factors and bacteria itself interact with the host immune system and initiate inflammatory responses.
Moreover, bacteria may persist at distal sites disseminating virulence factors that act as soluble antigens thereby provocation leucocytes, endothelial cells and hepatocytes to respond to bacteria/virulence factors with secretion of pro-inflammatory immune mediators [cytokines, chemokines, C-reactive protein (CRP)]. With continued exposure, soluble antigens react with circulating specific antibody to form immune complexes that further amplify inflammation at sites of deposition.
In industrialized countries, approximately 50% of the adult population suffers from moderate or severe periodontitis. Basic periodontal therapy usually comprises mechanical debridement of the teeth. It is the disruption of biofilm, followed by lifelong maintenance therapy.
Traditional periodontal therapy involves elimination of periodontopathogens by mechanical debridement, such as scaling and root planing (SRP) and surgical procedures in conjunction with proper plaque control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Systemically healthy individuals
- •Presence of at least 20 teeth excluding third molars.
- •PH individuals defined as <10% bleeding sites with probing depths ≤3mm.
- •Periodontitis criteria:
- •Stage III periodontitis with ≥30% teeth involved and bleeding on probing with >30% sites involved.
排除标准
- •Confirmed or assumed allergies or hypersensitivity reactions to amoxicillin and/or metronidazole.
- •Alcohol consumers.
- •History of systemic medication affecting the periodontal conditions, e.g. steroids, immune suppressants, antibiotics, anti-inflammatory drugs, statins, lipid lowering drugs, anti-convulsants, anti-coagulants, anti-hypertensives or any other host modulatory drugs within 6 months of commencing the study.
- •Had received any periodontal treatment in the previous 12 months.
- •Undergoing or require an extensive dental or orthodontic treatment.
- •Pregnant or breastfeeding women.
- •Current or former users of tobacco in any form.
结局指标
主要结局
High senstivity C-reactive protein (hsCRP)
时间窗: 2 months
For assessing marker of systemic inflammation, serum samples will be collected from venipuncture in antecubital fossa after an overnight fasting.
次要结局
未报告次要终点